Analytical Services Chemist II

Lannett Company; Seymour, Northern (IN, KY); Hybrid; USD 55,000 - 85,000; Full time

Job summary

Lannett Company in Seymour, Indiana, seeks a skilled laboratory analyst to perform testing of raw materials, packaging materials, in-process and finished drug products in a cGMP environment.

The role includes method transfer/validation, analytical method development and cleaning validation, with emphasis on accuracy, documentation and regulatory compliance. You will maintain notebooks, generate reports, and support cross-functional teams in delivering quality pharmaceutical products.

Qualifications

• Experience working in the pharmaceutical industry and/or analytical laboratory preferred
• Knowledge of cGMP, USP/NF, and FDA guidelines and regulations
• Expertise in analytical methods and lab instrumentation
• Excellent oral and written communication skills
• Strong organization, time management and troubleshooting skills
• Demonstrated ability to work as part of a cross-functional team
• Basic knowledge in Microsoft Word and Excel
• Experience with Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)

Responsibilities

• Perform routine and non-routine physical and chemical tests on raw materials, API, in-process, finished products, and stability samples
• Testing includes pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, HPLC impurities/assay, Dissolution, Residual Solvents by GC, and wet chemistry titrations
• Execute method transfer/validation protocols for basic analytical test methods per ICH/FDA/USP requirements under minimal supervision
• Draft method transfer/validation reports for basic analytical methods under minimal supervision
• Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate reports
• Document all laboratory testing and maintain notebooks and records
• Provide regular progress updates on projects
• Comply with all relevant regulatory requirements
• Maintain professionalism and support team members' self-esteem
• Perform laboratory troubleshooting and implement solutions
• Handle other projects and duties as required

Skills

cGMP knowledge

USP/NF guidelines

FDA guidelines

Analytical methods

HPLC

GC

Dissolution

Wet chemistry

LIMS

CDS

Microsoft Word

Microsoft Excel

Oral and written communication

Teamwork / cross-functional

Troubleshooting

Education

BS in Chemistry or related field

Tools

HPLC instrumentation

GC instrumentation

Dissolution testers

LIMS software

CDS software

Job description

Description

Summary

This position is primarily responsible for the laboratory testing of raw materials, packaging materials, in-process, release and stability samples for pre-commercial drug products, including the evaluation of new raw materials, new packaging materials, reference standard qualifications, method transfers, and method validations within the framework of cGMP compliance guidelines.

Responsibilities

• Perform routine and non-routine physical and chemical tests and assays on raw materials, API's, in-process, finished products, experimental batches and associated stability studies
• Testing performed to include basic and complex lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, Assay/Impurities by HPLC, Dissolution, Residual Solvents by GC, and wet chemistry techniques such as titrations and sample derivatizations
• Execute method transfer/validation protocols for basic analytical test methods for drug substance/product assay/dissolution/ residual solvents according to ICH/FDA/USP requirements under minimal supervision
• Draft method transfer/validation reports for basic analytical test methods for drug substance/product assay/dissolution according to ICH/FDA/USP requirements under minimal supervision
• Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate analytical report with supervision.
• Document all laboratory testing and maintain accurate and legible notebooks and records
• Provide regular update progress reports of projects
• Comply with all relevant regulatory requirements
• At all times strive to maintain the self-esteem of individual team members and the professionalism of the group as a whole
• Perform laboratory troubleshooting, propose solutions and implement
• Other projects and duties as required or assigned

Experience

• BS Degree in Chemistry or related field and 2 - 4 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment

Requirements

Skills

• Experience working in the pharmaceutical industry and/or analytical laboratory is preferred
• Knowledge of cGMP, USP/NF, and FDA guidelines and regulations
• Expertise in analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry)
• Excellent oral and written communication skills
• Strong organization, time management, leadership and troubleshooting skills
• Demonstrated ability to work as part of a cross-functional team
• Basic knowledge in Microsoft Word and Excel
• Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)